African American women account for 66% of HIV infections in women in the U.S., AIDS is a leading cause of death for African American women, and African Americans have the lowest medication adherence rates compared to other groups in the U.S. One of the reasons for low medication adherence among African Americans is fear of stigma. HIV stigma has been linked to depression, psychological distress, poor quality of life, poor medication adherence and service utilization contributing to morbidity and mortality. Research has found that stigma is a moderator to poor adherence via depressive symptoms.

The current study is a randomized control trial with a time and attention control group to test the effectiveness of a stigma reduction intervention adapted for use with African American women. A total of 224 African American women will be recruited to participate in the study. Half of the women will be from Chicago, Illinois (112) and the other half will be from Birmingham, Alabama (112). A workshop will be held once a study site has recruited 28 women, half of the women will be in the intervention group (14) and the other half will be in the control group (14). Each study site will have 4 cohorts of 28 women.

The main aims of the current study are:

to determine the long-term effectiveness of the intervention to reduce stigma for African American women living with HIV in Chicago Illinois and Birmingham, Alabama

to explore whether stigma reduction due to the intervention is moderated by location (Chicago vs. Birmingham), transmission risk factor, time since diagnosis, and perceived social support

We expect that the multimedia workshop intervention will demonstrate effectiveness in reducing internalized stigma through an easily-disseminated method, and that it will have a positive impact on medication adherence and engagement in care for African American women living with HIV.

Research assistants will access participants' medical records to see if patients have missed any HIV related visits (i.e. medical, counseling). Engagement to care will be measured as a proportion (missed visits over total scheduled). Rescheduled visits will not count as missed visits. At baseline, we will look at visits for the past 12 months.

We want to examine whether stigma reduction due to the intervention is associated with improved physical health bio-markers such as suppression in HIV viral load in the blood (taken from medical chart/previous clinical blood tests).

The intervention is a workshop facilitated by a peer advocate (an African American woman who is also HIV positive) and a social worker. It has exercises, videos and group discussions intended to equip participants with coping skills to overcome HIV related stigma and the negative outcomes related to stigma. The workshop will last about 8 hours total across 2 two days (4 hours per day). The researcher in the current study has done a lot of work in adapting this intervention for African American women. The workshop has been piloted in Seattle and had promising results. Based on results in the pilot study, a 2 hour booster session has been added 6 months after the initial workshop

Behavioral: Unity Workshop

The intervention is based on other stigma reduction programs that are being used internationally (HIV Stigma Toolkit developed by the International Center for Research on Women and trigger videos developed by International Training & Education Center for health).

Breast Cancer Screening

The time and attention control group workshop will be facilitated by a research coordinator. The control group program is based on another program that is designed explore issues related to breast cancer screening among African American women. The program has the same format as the Unity Workshop, with video and group discussion. Although breast cancer may be associated with stigma, we anticipated that breast cancer stigmas would not be related to HIV-associated stigma, which is our primary outcome of interest. The control groups will be held during the same week as the Unity Workshops, and control group participants will complete assessments on the same schedule as the Unity Workshop participants.

Behavioral: Breast Cancer Screening

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

they are women who identify as having an African American racial/ethnic background

born in the U.S. (including women of Caribbean origin if born in the U.S.

speak and understand English as their primary language of communication outside the home

they are 18 years of age or older

have a documented HIV positive status (women are on antiretroviral treatment and women who are not on antiretroviral are eligible)

able to see and interact with a touchscreen computer in English.

Exclusion Criteria:

women who not self-identify as African American

women who are African born or born outside the United States

younger than 18 years of age

unable to provide informed consent

life expectancy less than 1 year per physician report

unable to see and interact with a touchscreen computer in English.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01893112